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Regulating Digital Therapeutic Cybersecurity: Today and Tomorrow
Cybersecurity has become a concern for Digital Therapeutics (DTx) developers and regulatory bodies. Learn to balance functionality &...
The Ultimate Guide to Post-Market Surveillance: What You Need to Know
In today’s rapidly evolving regulatory landscape, ensuring medical device safety and performance goes beyond the approval phase. Effective...
PMCF & RWE: Roles of Medical Device Registry Studies & ePROs
Registry studies focused on a specific medical device are a valuable tool to capture the safety and outcomes...
Why Remote Consent Is the New Normal in 2021
COVID-19 changed the conversation around enrollment and recruitment for clinical trials. Learn how eConsent is helping researchers do...
Top 4 eConsent Questions from Clinical Researchers
In September 2020, Castor CEO Derk Arts, MD, Ph.D., led a webinar on electronic informed consent (eConsent) challenges...
UKCA Mark: 7 Steps to Prepare Medical Devices for Brexit
In the wake of Brexit, medical device companies secure a UKCA mark as proof of conformity to place...
Impact of ISO 14155 on PMCF Investigations Under the MDR
Through the Medical Device Regulation (MDR) and new version of ISO 14155, the regulatory landscape for clinical investigations with...
Impact of COVID-19 and the Imminent MDR Delay
Introduction The implementation of the new EU Medical Device Regulation (MDR) just got a plot twist: COVID-19. This...
Forecasting the impact of COVID-19 on medical device trials
As of early April 2020, over 1,000,000 people have been confirmed infected with the SARS-CoV-2 coronavirus, and governments...
6 Steps for Using eCOA / ePRO & Physician Surveys to Fulfill MDR PMCF
To ensure ongoing regulatory compliance under the EU MDR, medical device manufacturers must demonstrate the safety and performance...
How we’re gearing up for GDPR
In the past two decades, technology has drastically changed how we capture, use, and store data. As a...